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FDA, Food & Drug Administration, hip, Howard Sadwin, Medical device, Smith, Smith & Nephew, UNited States
Great to see the activity pick up re: metal on metal hip devices, and yes they can be hazardous to your health, although Vicky Marlow has several valid points Smith and Nephew have some good products, devices on the market that have save or helped thousands of people.
However they used a device that’s materials were not compatible.Introducing
a foreign body into our bodies doesn’t work all the time, people’s bodies do not always accept the new body part. Resultingly, a condition can take place within the hip patients that causes the loss of all the tissue or severally damages,deteriorates other tissue and muscle that once supported my hip.
Yes Vicky there are more success stories via BHR,and that is great, there are more and more people coming forward with BHR problems. Some may be human error,some maybe from unexpected fall, some because not compatible with some humans.
The number of these people is increasing, in time you will see cases filed.
In 2004, the BHR was denied approval in the USA through a pma program. There was a single patient group supplying all the statistical research data, this group was from out of this country, McMinn one of the BHR inventors worked for Smith+Nephew, and he reportedly was payed $50 million dollars more or less once the BHR was approved. Plus the application was missing other required information. So the device was turned down. The FDA also expressed concern regarding metal particles in our bodies what would the outcome be.
In 2006 using all the same data used in the pma approval attempt of 2004 the BHR was approved in the USA. The approval did have stipulations: one I recall had Smith+Nephew reporting every 6 months as new things learned re: metal on metal shavings entering the human body.
Vicky I don’t understand your 14 years of use, not in this country if got its approval in 2006.
I don’t think any medical device manufacturer could give you much data about these new hips. How long to they work, limitations, can they cause harm to one’s health, including the materials used as being the bad guy.
BHR came into our market place when DePuy,ASR,Stryker, etc. were having problems with their metal on metal hip devices, so it was an opoprtune time to market a new and greatest hip, BHR. The data could have easily been tainted considerating the times. Smith+Nephew paid part of a $311 million dollar fine along with 4 other large device manufacturers. Payment of the fine stopped the Federal Government from pursuing a case involving kickback payments, to doctors, hospitals,distributors etc. some of these bonuses were vactions (hunting,fishing) cars, house, low interest loans. Several of these same companies got caught again. Now the FEDS are investigating PODS, a means or vehicle used to pay other parties indirectly.
You all must get yourselfs well and strong first, then tackle the giants if you had or have a valid claim.
Be patient this will be tough, on you even moreso than what you are going through now. Don’t get down in a whole sometimes we feel a little sorry for ourselves because of what has happened to us physically, mentally,financially,family and what has happened to me as an individual.
Respectfully
Howard Sadwin
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Howard,
When you look at the longevity and data of a device and it’s success or failure rates, you look at when it first hit the market, ANY where in the world. There are many patients on here that are NOT from the U.S. so this July the BHR is going on 15 years. With some patients celebrating 20 years last year if you count the first prototype.
http://www.hipresurfacingsite.com/Hip-Stories/20090321408/Other-Patients/Katie-Ellis/menu-id-30.html
Also check out the date of every implant in the Australian Registry and look at the date there, completely unbiased data.
http://www.hipresurfacingsite.com/Ortho-Conferences/Ortho-Conferences/menu-id-58.html
The numbers are just not there. And you still refuse to get other opinions on the placement of your component which still makes me very suspicious as to your reasoning behind all of this. I mean I offered to get you FREE opinions from some top surgeons and yet you refuse. MOST of the failures for the BHR are due to misplaced components, in an extremely small percentage of patients, they will have a well placed BHR and still end up with problems, those are the ones usually with true metal allergy. I do not understand your motive behind this at all. Metal on metal knees have been implanted for years. Yes, you will absolutely find some failures of BHR’s because there is NO such thing as any surgeon having a 100% success rate it just does not exist. The Depuy on the other hand recalled their device because CLEARLY it was defective. But most of the BHR failures I have seen are horrible placed components, here are some examples
http://www.hipresurfacingsite.com/X-Rays-Problem-Cases/Xrays-Problem-Cases/menu-id-114.html
And here
http://www.hipresurfacingsite.com/component/option,com_rsgallery2/Itemid,67/gid,15/
Again, ANY poorly placed component is going to cause problems no matter what material it is made out of, that is just a fact.
A very few patients with well placed components as I have mentioned before will end up with a true metal allergy which is extremely rare.
Why will you not answer me about getting opinions on the placement of your component? Is your whole thing here based on monetary gain? I do not understand WHY you would turn down getting anonymous opinions for FREE from some top surgeons? Why blame it on the device when it could be the doc or hospital to blame?
Vicky
Hi All: I can’t comment on other’s situations after having revisions from failed resurfacings or metal on metal THR’s. I had bilateral revision surgery last October from failed Conserve Plus resurfacing acetabular components. My surgeon is one of the best in the world for dealing with metallosis due to MoM ions shedding. My levels were quite high, although I was not in any great pain. I had pseudo tumors, and actabular bone loss that required 5 hours of surgery to repair.
I now have two Stryker Dual Mobility THR’s. I am doing very, very well. I am back in the ballet studio five days a week, dancing again WITH NO RESTRICTIONS. Actually, my new components give me more range of motion than the resurfacing components did.
I was lucky to be able to have this very serious situation come to a successful conclusion, and am pleased to state that I am in communication with several others for whom this is the case, as well..
Many factors lead to an early failure (I was only 5 1/2 years out from my resurfacing surgery). The two main ones are surgeon error in placement and device defect. The majority of people getting either a resurfacing or a THR go on to enjoy many, many healthy, active years. It is not the case that all failures will lead to life long impairment. Also, it is very important to note that a mechanical failure which includes metal ions damage is NOT LIKE a failure due to deep infection. That is something entirely different, and requires its own special medical protocol.
Happy Dancer